Public Citizen welcomes the opportunity to comment on the agency’s Proposed Rule on risk assessments conducted by the Occupational Safety and Health Administration (OSHA) and the Mine Safety and Health Administration (MSHA).[1] The Proposed Rule is a parting gift from an outgoing administration to its supporters in industry and should be withdrawn.

During the nearly eight years the current administration has been in power, only a single major health rule (hexavalent chromium) has been promulgated by OSHA – and that only after a lawsuit brought by Public Citizen on behalf of itself and the United Steelworkers of America. We would like to share our experiences from that rulemaking with you, as they shed light on the serious deficiencies in the Proposed Rule.

Requirement for an Advanced Notice of Proposed Rulemaking

The Department proposes that an additional major step in the already cumbersome regulatory process be added: an Advanced Notice of Proposed Rulemaking (ANPRM) to precede the Proposed Rule and the Final Rule. We oppose this proposal because it will further delay regulatory action by agencies now considered synonymous with delay.

The Department claims that the hexavalent chromium regulation was preceded by an ANPRM. This is not correct. On August 22, 2002, OSHA issued a Request for Information, not an ANPRM. (As the use of such requests in this and other instances indicates, the agency has many methods of obtaining the information it seeks short of an ANPRM.) On December 4, 2002, the agency announced that it would regulate hexavalent chromium, but this was in the form of a press announcement, not an ANPRM. On December 24, 2002, the U.S. Court of Appeals for the Third Circuit ruled against OSHA, requiring the agency to regulate the chemical.

The subsequent regulatory proceeding provided multiple opportunities for the agency to obtain the information it sought from all involved parties. Even before the agency formally initiated its rulemaking proceeding, the industry was submitting copious entries to the docket. Aside from the Request for Information, these opportunities for input into the regulatory proceeding included the Small Business Regulatory Enforcement Fairness Act (SBREFA) process, meetings of the Advisory Committee on Construction Safety and Health and the Maritime Advisory Committee on Occupational Safety and Health, comments submitted in response to the Proposed Rule, the 11-day hearing on the Proposed Rule, and post-hearing comments. Indeed, repeated requests for further data were a consistent aspect of the hearings. There was thus no shortage of opportunity for input in the three-year rulemaking process.

Despite these evidently sincere requests for information, we are not convinced that they substantially altered the regulatory process. The agency is quite capable of finding all the published reports in the medical literature and those produced by U.S. government or international groups. The industry, for its part, practically deluged the government with documents, including re-analyses of medical articles in the docket.

In many cases, however, the agency seeks a degree of detail in exposure measurements and technological and economic feasibility assessments that no involved party will be able to provide. They will be no more able to provide these if an additional requirement for notice and comment is promulgated. For example, we submitted to the docket one of very few comprehensive, peer-reviewed, assessments of hexavalent chromium exposure ever published.[2] Yet the agency did not even cite our paper in the Final Rule. We mention this not to complain, but rather to acknowledge that our study, which was based on all OSHA measurements of hexavalent chromium exposure during agency inspections from 1990 to 2000, was simply not finely grained enough for the agency’s regulatory purposes. For this reason, the agency engaged the services of contractors who turned in reports running into the hundreds of pages on exposures, technological feasibility and economic feasibility. The agency’s pleas for additional data produced very little to undermine the contractors’ reports.

On the other hand, the industry proved quite able to distort the record in its selective submissions to the agency. In a paper published in a peer-reviewed journal,[3] we demonstrated how the industry withheld certain critical data from OSHA, divided a study in two to reduce statistical power, cited the underpowered study in its post-hearing comments to OSHA, and combined exposure categories in a subsequent paper to obscure the fact that its own research showed elevated lung cancer risks at exposures close to those that OSHA later deemed acceptable. Adding another opportunity for notice and comment will do nothing to address these sorts of manipulations; if anything, it will provide more opportunities to distort the record. And it will add needless years to a regulatory process that, in the case of hexavalent chromium, stretched from 1993, when we first petitioned the agency, to 2006, when the court-imposed regulation was finally issued.

Three further observations are in order. First, as the Proposed Rule acknowledges, the Department already has the authority to issue ANPRMs and has been quite able to issue rules without issuing an ANPRM. Why the sudden need to require ANPRMs for all rulemaking proceedings? Second, whereas ANPRMs typically do not require point-by-point responses in the Proposed Rule to all issues raised by commenters to the ANPRM, this proposal would require such responses, a major increase in regulatory burden. Finally, we are concerned that the requirement for an ANPRM could be enforced retroactively to rulemakings already proceeding but in which an NPRM has not yet been issued. The last thing we need in the slow-motion regulation of beryllium (now seven years since Public Citizen’s petition to reduce the Permissible Exposure Limit) is a Go Directly to Jail card in the form of a requirement for an ANPRM.

It almost goes without saying that adding another layer of notice and comment to an already clumsy rulemaking process is inconsistent with the policies of an administration that has declared itself hostile to bureaucratic red tape. But then this is an administration that cannot even follow the existing red tape. The Proposed Rule was not published in the most recent agency Regulatory Agenda, as required, and violates White House Chief of Staff Joshua Bolten’s edict that no Proposed Rules other than those involving “extraordinary circumstances” should be issued after June 1, 2008.[4] A regulation that will do no more than further hamstring an agency that does little of substance unless it is staring down a court order hardly meets the definition of an “extraordinary circumstance.”

Definition of “Working Life”

The version of this proposal submitted to the Office of Management and Budget included an extensive discussion of workers’ lifetime tenures in particular jobs and occupations and made the argument that the agency scuttle its standard assumption that its risk assessments be based on a 45-year working lifetime.[5] The agency argued that, because workers might not be exposed to the chemical hazard for the entirety of their working lifetimes, a downward-adjustment of risk (and, implicitly, an upward-adjustment of Permissible Exposure Limits) was justified.

The version of the Proposed Rule ultimately published in the Federal Register removed this section. Yet, the concepts live on in more subtle form. On page 50912, the agency expresses interest in industry-by-industry exposure “duration” and on page 50913 again makes mention of the need to consider “duration of exposure” and “duration of employment” (footnote 33).

While we certainly welcome the downgrading of this concept, we would like to offer some comments on why the 45-year working life assumption has been utilized since the very creation of the agency.

First, the statute requires that “no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard … for the period of his working life.”[6] The plain meaning of this language is that, even if workers were generally not exposed to the hazard for the entire duration of their time in the workforce (because, for example, most workers do not stay in the industries involved for their entire working lives or tend to move out of positions that involve exposure even while remaining in the industry), standards implementing the statute must provide protection sufficient to protect them if they were exposed for that period. Critically, even workers who move between jobs often perform the same tasks and are exposed to the same hazards at subsequent jobs. Thus a welder may move from one construction site to another, but still function as a welder with the same attendant hazards.

Second, the 45-year working lifetime provides a workable default assumption, one that has been standard in occupational health for decades and to which there is no obvious alternative. In this respect, at least, occupational health regulations have been standardized.

Third, there is nothing in the statute that requires that only average risks (or the risks experienced at some percentile of exposure) be mitigated. Rather, the statute requires that “no employee will suffer material impairment of health …” It seems preposterous to allow the experiences of those with the least exposure to drive down levels of protection for those exposed the most.

Finally, the OSHAct and the Mine Act do not build in any margin of safety the way the Food Quality Protection Act of 1996 does. Given the uncertainties that inevitably attend risk assessments in occupational health, such a margin of safety is sorely needed. The 45-year working lifetime assumption in effect accomplishes this.

For these reasons, we urge the Department to desist from any attempts to redefine a working life. The inevitable consequence of such a redefinition will be a dramatic reduction in protection for workers. Given the linear models the agencies typically rely upon, a 50% reduction in the assumed working lifetime will translate directly into a two-fold increase in the Permissible Exposure Limit.

We do not question the agency’s right to include in its risk assessments for comparative or illustrative purposes data that estimate risks based on working lifetimes of less than the standard 45 years, as it did in the hexavalent chromium rulemaking. But, in the end, we remain convinced that any regulation promulgated under an assumption of a reduced lifetime of exposure would be illegal.

We urge the agency to withdraw this last-minute present to the regulated industries. The clear purpose of the Proposed Rule is to firmly apply handcuffs to the new administration, miring it in red tape lest it enact worker protections more stringent than those established by the current administration.

Yours sincerely,

Peter Lurie, M.D., M.P.H.
Deputy Director
Health Research Group at Public Citizen

Scott L. Nelson
Senior Attorney
Public Citizen Litigation Group

Sidney M. Wolfe, M.D.
Director
Health Research Group at Public Citizen

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